Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00517777
First received: August 15, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 15, 2007
August 15, 2007
August 2007
Not Provided
  • metabolic syndrome [ Time Frame: one year ]
  • left ventricular mass [ Time Frame: one year ]
  • diastolic function [ Time Frame: one year ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage
Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome

To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea Syndrome
  • Metabolic Syndrome
  • Cardiac Remodelling
  • Continuous Positive Airway Pressure Ventilation
  • Device: continuous positive airway pressure ventilation
    nighttime
  • Behavioral: dietary and life style recommendations
  • Experimental: 1
    continuous positive airway pressure ventilation + dietary and life style recommendations
    Interventions:
    • Device: continuous positive airway pressure ventilation
    • Behavioral: dietary and life style recommendations
  • Active Comparator: 2
    dietary and life style recommendations
    Intervention: Behavioral: dietary and life style recommendations

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2010
Not Provided

Inclusion Criteria:

  • moderate to severe sleep apnea syndrome

Exclusion Criteria:

  • cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
  • thyroid diseases
  • diabetes
Both
25 Years to 70 Years
No
Not Provided
Italy
 
NCT00517777
1113
Yes
Not Provided
Università degli Studi dell'Insubria
Not Provided
Principal Investigator: anna maria grandi, MD Università degli Studi dell'Insubria
Università degli Studi dell'Insubria
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP